Devices and methods for treating restless leg syndrome

ABSTRACT

A method and system for treating restless leg syndrome.

This application is a continuation of U.S. application Ser. No.12/396,358, filed Mar. 2, 2009, now U.S. Pat. No. ______, which claimspriority under 35 U.S.C. §119 to U.S. Provisional Application61/032,571, filed Feb. 29, 2008, the entirety of which is incorporatedby reference herein.

FIELD OF THE INVENTIONS

The present invention relates to devices, systems, and processes usefulto treat Restless Leg Syndrome.

BACKGROUND OF THE INVENTIONS

In 1685 Thomas Willis, an 17th century English physician, published thefirst description of what we now term “restless legs syndrome”(“RLS”).(1,2) He characterized patients with this disorder as,“Wherefore to some, when being a bed they betake themselves to sleep,presently in the Arms and Legs Leapings and Contractions of the Tendons,and so great a Restlessness and Tossing of their Members ensure, thatthe diseased are no more able to sleep, than if they were in a Place ofgreatest Torture.” In 1945, Karl Axel Ekbom coined the term “restlesslegs syndrome” and suggested a neurological instead of a psychiatricorigin to the disorder.(3) Ekbom focused attention on the abnormalsensory component of the disease.

With development of “Sleep Labs” in the 1970's, the sleep-robbing natureof RLS was objectively characterized.(4) In 1990 the American SleepDisorders Association defined RLS as (i) disagreeable touch sensationsseemingly originating in the legs, that (ii) come upon some nights andnot other nights, and that (iii) are relieved almost immediately uponstanding or walking. In 1999, a task force of the American Academy ofSleep Medicine summarized the then current understanding of RLS.(5)Diagnostic criteria were further expanded in 1995 and 2004 byinternational groups to include episodes occurring during the daytimewhen drowsy.(6,7)

Disagreeable touch sensations were cataloged as “creepy-crawly, antscrawling, jittery, pulling, worms moving, soda bubbles in veins,electric shock, pain, the gotta moves, burning, jimmy legs, hebbiejeebies, tearing, throbbing, tight feeling, grabbing, Elvis legs,itching bones, crazy legs, and fidgets.”(7) With symptom descriptions asbizarre as these, it is no wonder that early investigators lumpedpatients with RLS in with patients with psychiatric hysterical(conversion) disorders. However, clinical responses to variouscategories of (8) drugs and to iron therapy and the presence of at leasttwo genetically identifiable phenotypes all argue in favor of a physicaland not a psychological origin to RLS.(9)

RLS is a common disorder: prevalence of symptoms 5 or more nights permonth were reported in 3% of individuals 18-29 years, 10% in 30-79years, and 19% in those 80 or older.(10) Age adjusted prevalence in thisstudy was 10%. In a similar study, prevalence was 11.5% with half ofthose reporting RLS symptoms causing moderate to very severediscomfort.(11) Others have described a rise in prevalence with age buthave set peak prevalence at 70-79 years with a slight drop off in people80 years and older.(12) Whatever the peak prevalence of RLS, it is morecommon in older individuals than younger and it severely affectsemotional well-being in the elderly.(13,14)

A study of 23,000 individuals conducted in France, Germany, Spain, andthe UK concluded that 11.1% of the general population have RLS and thatin 50% of patients RLS symptoms significantly disrupted everydayactivities and personal relationships.(15) A companion study of over15,000 individuals determined that 5% of the population had RLS attacksat least twice weekly.(16) RLS is now sufficiently common that in the2007 issue of Time Magazine it was featured in “The Year in Medicinefrom A to Z”.(17) Although quite common, RLS is not commonly recognizedby primary-care physicians even when a diagnostic description is givenby the patient to his doctor.(18) However, when primary-care physiciansare made aware of RLS, they can identify RLS in a high proportion ofpatients.(19,20)

RLS can be early in onset (before the age of 45) with slow progressionof symptoms and run in families, or it can come on later in life,involving one member of a family with rapid development of severesymptoms.(12,21-24)

Because RLS is common, it has been observed in association with a widevariety of other disorders and diseases. Some have interpreted theseassociations as causal links. Such causal interpretations need to beviewed with great caution. The list includes metabolic and hormonalabnormalities, pregnancy, peripheral neuropathies, spinal and brainstemlesions, decreased serum magnesium and folate levels, anemia, rheumatoidarthritis, amyloidosis, carcinoma, musculoskeletal disease, anxiety,depression, multiple sclerosis, cognitive defects, hypertension, blooddonors, heart disease, reduced libido, social isolation,gastroesophageal reflux, migraine headache, chronic lung disease,caffeine use, varicose veins, sleep apnea, gastric surgery, drugwithdrawal, hypothyroidism, acute intermittent porphyria, arborizingtelangiectasia, cholesterol microemboli, diabetes, periodic limbmovement disorder in sleep (PLMS), somatoform pain disorder, beingCaucasian, and more.(2,25-40,40-45)

However, by 2007, only two published studies of patients selected fromthe general population accurately measured the association of RLS withother disorders.(46,47) These two studies found that diabetes, reducedrenal function, and anemia are significantly associated but make only asmall contribution to the overall prevalence of RLS. Even in the olderage groups where the RLS is most prevalent, secondary disorders anddiseases increase RLS prevalence by only 10-20%.

Unlike these two general population studies, many small associativestudies have identified patients with specific disorders or diseases andthen compared RLS prevalence in these selected populations with thegeneral population or with controls. In a review of 16 publicationsfocused on patients with end-stage renal disease on dialysis publishedbetween 1991-2005, 15 (93.8%) of the 16 studies demonstrated higherprevalence rates in these dialysis patients than in the generalpopulation.(36) In one study, 84% of patients with end-stage renaldisease had RLS. To support this association, it has been observed thatin some patients, symptoms of RLS dramatically decrease following renaltransplantation.(48) Like RLS in others, in dialysis patients RLS leadsto poor sleep and thereby to a low quality of life.(49) Patients withRLS suffer from daytime sleepiness, depression, poor concentration, andeven fear of long-distance travel during which their legs may becomerestless while awake.(9)

In a publication examining RLS and pregnancy, four studies demonstratedprevalence rates higher than the general population, while one showedrates no different that those observed in the general population.(36)Others have reported an association of RLS with pregnancy.(50) Thisassociation is further supported by the observation that the frequencyof RLS attacks drops dramatically following childbirth.(51,52) Goodmanet al. present a very convincing reverse “S” shaped-curve showing adramatic decrease in RLS episodes following delivery.(53) In anotherstudy of pregnant women, an association was observed between RLS andparity.(47) Women who had given birth to three or more children had athree times greater risk of having RLS compared to nulliparous women orto men.

Iron deficiency has been associated with RLS since 1945, although theconnection between the two disorders is not clear-cut.(3,36,54)Correction of peripheral anemia does not always decrease RLS symptoms.Furthermore, most patients with RLS are not anemic. When studied bymagnetic resonance imaging, iron abnormalities associated with RLS wereobserved in the substantia nigra of the brainstem.(55) Decreased serumferritin (below 50 ng/mL) and cerebral spinal fluid ferritin levels havebeen associated with RLS.(2) Patients with RLS appear to have adecreased ability to transport iron into the central nervous systemthrough the blood brain barrier.(56)

A wide variety of peripheral neuropathies have been connected with RLSincluding cryoglobulinemia, Charcot-Marie-Tooth ataxia type 2, diabetic,and amyloid types.(57-60)

To prospectively evaluate the concomitant occurrence of RLS and varicoseveins in a population seeking treatment for varicose veins, and toassess the therapeutic response of RLS to sclerotherapy, 1397 patientswith varicose veins were screened for RLS symptoms by questionnaire andinterview. RLS symptoms were present in 312 (22%) of the 1,397 patients.Sclerotherapy with sodium tetradecyl sulphate was performed on 113 RLSpatients. 111 (98.2%) of 113 treated patients reported initial relieffrom RLS symptoms. Follow-up showed recurrence rates of 8% and 28% at 1and 2 years, respectively.(61)

And finally, RLS has been associated with the phenomenon of periodic legmovements in sleep (PLMS).(30) In 1953, Symonds described an involuntaryclonic-like movement of the lower extremities that occurred duringsleep, often waking the patient over and over again at night.(62) In1965, Lugaresi et al. documented the presence of PLMS in patients withRLS.(63) In a polysomnographic study of 133 individuals with RLS,Montplaisir et al. observed PLMS in 80.2% of these individuals using aone-night's sleep PLMS index score of greater than 5 (one of the manydefinition of abnormal PLMS).(64) However, PLMS has also been observedin association with other forms of insomnia such as narcolepsy,rapid-eye-movement sleep disorder, and obstructive sleep apnea.(7) Ithas also been observed in normals.(7) Because RLMS is associated withmany diseases and disorders and with normals, patients with RLS compriseonly a fraction of patients with PLMS. At best the diagnosis of RLMS is“supportive” of the diagnosis of RLM; it is not diagnostic.

If RLS is caused by one of these associated disorder or disease, and ifcorrection of the associated disorder or disease can stop the symptomsof RLS, then treatment is straight forward: treat the associateddisorder or disease. Except for pregnancy and some forms of anemia,these associative disorders or diseases are not generally amenable totreatment. For most of these patients, palliation of RLS symptoms is theonly treatment available.

On the other hand, in the vast majority of patients suffering from RLS,there is no associated disorder or diseases of the legs.(26) That is, inmost individuals, RLS is idiopathic or primary in nature.(65) Theiraffected limbs are no different than limbs of people without RLS. Skin,muscles, bones, nerves, arterial or venous circulation, spinal reflexes,electromyography, nerve conduction studies, and imaging examination areall normal in patients with primary RLS.(12,52)

In patients with primary RLS, the anatomic site of origin of RLS appearsto be in the central nervous system above the level of the spinal cordand below the level of the cerebral cortex.(12) The site of origin maybe at the subcortical level, perhaps at the level of the thalamus andcerebellum.(66)

FIG. 1 includes an illustration showing a leg and the major classes ofsomatic sensory receptors, highly specialized cells associated withneurons that convert various forms of energy from physical stimuli intonerve impulses. The hairy skin H (including free nerve endings,nociceptors, Merkel's disks, and Ruffini's corpuscles), periosteum andinterosseous membrane P (including Pacinian corpuscles), thegastrocnemius muscle, muscles M including muscle spindles, glabrous skinG (including free nerve endings, nociceptors, Merkel's disks, andRuffini's corpuscles, and Meissner's corpuscles), joints J (includingjoint receptors), tendons and ligaments T (including Ruffini'scorpuscles and Golgi tendon organs), and subcutaneous tissue S(including Pacinian corpuscles) are illustrated (67).

Whether secondary or primary, central to RLS is the nighttime onset ofdisagreeable somatic sensations that appear to originate in a leg or inlegs. Of our five senses, touch is the most heterogeneous in character.Touch encompasses the sensation of pain and temperature, pressure andcrude touch, fine or discriminatory touch, and vibratory sensation. Avariety of specialized microscopic receptors or mechanical-electricaltransducers are present in skin, subcutaneous tissues, muscles, tendonsand ligaments, joints, and periosteum and interosseous membranes todistinguish different types of touch sensations, as shown in FIG. 1.These specialized transducers or filters include Pacinian corpuscleswhich are encapsulated, onion-like nerve coverings that sense deeppressure and vibrations in the 250-350 Hz range; Meissner's corpuscleswhich are oval structures surrounding nerve and located between dermalpapillae and which detect pressure and low frequency vibration in the30-50 Hz range; Merkel's discs which are spherical collection of cellsthat identify static pressure and respond to low frequency vibrations inthe 5-15 HZ range; Ruffini's corpuscles which are elongated structuresin the dermis that detect skin stretching and the sense of slipping;Golgi tendon organs, joint receptors, and muscle spindles that identifystretching, and free nerve endings that sense temperature and pain.(67)

Three distinct somatic sensory neuronal pathways exist for the legs.Each pathway begins in the leg and ends with a neuronal signals reachingthe cerebral cortex and, hence, consciousness.

Pathway No. 1: When painful stimuli or changes in temperature excite theleg, they cause sensory nerves in skin to fire. These primary neuronsthen synapse in the ipsilateral dorsal horn of the spine with secondaryneurons of the contralateral lateral spinothalamic tract. These lateralspinothalamic nerves then course up the spine reaching the thalamus onthe opposite side of the stimulus. In the thalamus, these axons synapsewith tertiary neurons that exit the thalamus and ascent in the internalcapsule and terminate in the postcentral or sensory gyrus of thecerebral cortex.

Pathway No. 2: Pressure and crude touch nerves follow a similar pathwaywith the addition of fibers from the primary neuron for several spinalsegments in the ipsilateral dorsal white matter column.

Pathway No. 3: Neurons that transmit the senses of fine ordiscriminatory touch, proprioception, and vibratory touch follow adifferent pathway to the thalamus. For the legs, the primary sensoryneurons ascend in the ipsilateral fasciculus gracilis of the dorsalcolumn of the spine to the ipsilateral nucleus gracilis in the medulla.In the nucleus gracilis these primary neurons synapse with secondaryneurons which then cross the midline to ascend in the contralateralmedial lemniscus to the thalamus. Tertiary neurons then ascend to thepostcentral or sensory cortex, just as with other touch sensations.Since this wide variety of somatic leg sensation all reach the thalamus,it makes sense that the unpleasant leg sensations in patients with RLSare very diverse in character.

For patients with primary or secondary RLS, the terribly unpleasanttouch sensations of RLS that often start during sleep are mapped totheir leg or legs (and, much less commonly, to their arm or arms). Sincemost patients are not actually being subjected to bizarre touchsensations in the affected extremity, the sensations are, in effect,somatic hallucinations. That is, these sensations are perceived tooriginate in a limb in which no corresponding stimulus is present. Forexample, at the time some patients with RLS report that a leg feels asthough worms are crawling in it, no worms are actually present toexplain the sensations experienced. The phantom limb syndrome inamputees is a similar phenomena, where somatic sensations in the brainare mapped by the individual to a limb that is not present. They are notusually referred to as “hallucinations,” but they are.

A partial explanation for the hallucinations that begin during periodsof sleepiness and drowsiness or during sleep in patients with RLS may befound in the neuronal circuit that exists between the thalamus and thesensory cortex, referred to as the “thalamocortical loop.”(67) Only twostable membrane potential states exist for thalamocortical neurons.During wakefulness, these neurons fire tonically which allows them totransmit information from peripheral somatic stimuli to the cortex orconscious brain (see Pathways 1-3 above). During sleep, and perhapsduring times of sleepiness or drowsiness, the thalamocortical neuronsenter an oscillatory state, become synchronized with the cortex, anddisconnect the cortex from the outside world. When disconnected, theconscious brain gets its peripheral somatic sensory input not fromperipheral somatic sensory neurons but from the thalamus and its variedinputs. The somatosensory brain is no longer looking at the externalworld; it is focused internally.

The primacy of sensory abnormalities in RLS—as opposed to movementabnormalities—was emphasized in a recent study published by pulmonaryphysicians (as opposed to sleep physicians) who noted that “Theendorsement of twitching or frequent body movements in the current studywas so frequent as to render it a nonspecific finding. We cannot drawany conclusions based on this reported symptom in this study, other thanto suggest that asking about body twitching may not be useful in theclinical evaluation of patients.”(37) The same authors noted that aconsistent diagnosis of RLS could be obtained using a definition of RLSthat requires “ . . . uncomfortable leg sensations a few nights a weekor more that are worse at night.” Abnormal brain somatosensoryprocessing in RLS patients has been described.(68)

Prior to waking, the unpleasant sensations of RLS lead to leg movementsseemingly as an unconscious attempt to diminish the amplitude of thedisturbing sensations. Dysfunctional leg movements and their antecedentunpleasant sensations wake the patient who then seeks relief by doingsomething, commonly getting out of bed and standing or walking. However,even though standing and walking diminish unpleasant limb sensations,they do so at the expense of sleep. Over half of patients with RLSreport waking with symptoms 3 or more times per night on nights theyexperience attacks.(15) Loss of sleep is the ultimate price paid by thepatients who suffer from RLS. RLS patients with severe symptoms have theleast amount of sleep of any sleep disorder with the exception ofsleep-loss associated with mania.(66) The sleep-loss of RLS leads to ageneralized decrease in quality of life similar to other forms ofinsomnia, such as sleep apnea.(15,69) RLS victims are more likely thannormals to be late to work, miss work, make errors at work, and misssocial events because of sleepiness.(37)

Two drugs are currently labeled by the Food and Drug Administration forthe treatment of RLS: Mirapex® (pramipexole dihydrochloride), a nonergotdopamine agonist, and Requip® (ropinirole hydrochloride), a nonergotdopamine agonist. Both agents have a higher binding affinity with D₃dopamine receptor subtypes than for D₂ for D4 receptors. In two separateblinded studies of ropinirole, very large placebo affects were observed,suggesting that just the process of focusing attention on patients withRLS helps them considerably.(70,71) Off-label drug prescription for RLSis widespread. Many drugs, including iron preparations, benzodiazepines,opiates, and anticonvulsants have been used to treat RLS.(8) Somedopaminergic agents, such as the combination of levodopa/carbidopa, havecaused long-term side effects which include worsening or augmentation ofRLS symptoms.(9) Drugs that influence the central nervous systemcommonly effect more than one region of the brain, making drugs lessthan desirable as a first line of treatment for RLS. McCrink et al.studied 16,202 individuals, 7% of which had RLS. They documented thathealth-related quality of life was actually diminished in RLS patientswho used prescription medications to treat RLS symptoms.(72)

As previously noted, if correction of a patient's secondary disorder ordisease can correct RLS, that disorder or disease should be treated.However, most patients with RLS have no secondary disease or disorder tocorrect or the secondary disorder or disease is not treatable.

To relieve the unpleasant tactile sensations of RLS, patients resort toall sorts of movements and stimulations of the legs including “ . . .walking about, stomping the feet, rubbing, squeezing or stroking thelegs; taking hot showers or baths; or applying ointment, hot packs, orwraps to the legs.”(73) As stated by Jones and Derodra, “The relief ofsymptoms produced by movement or rubbing may be due to the afferentsensory input effect.”(25) Patients are spontaneously applying anoverwhelming or swamping sensory input to serve as a“counterstimulation” to the unpleasant sensations of RLS. Once up anddoing something, RLS symptoms usually subside. However, the process ofgetting up and walking interrupts sleep. And interrupted sleep, over thelong haul, leads to decreased wakeful functioning and diminishedquality-of-life.

A simple device that could provide a pleasant sensation to overwhelm orswamp the unpleasant sensations of RLS, without fully waking thepatient, might be a more desirable first line treatment of RLS thandrugs. Counterstimulation is a known medical therapy. To treat auditoryhallucinations, personal stereo music has been applied as acounterstimulation to overwhelm or swamp auditory hallucinations.(74)Similarly, to treat a wide variety of chronic pain syndromes,transcutaneous electrical nerve stimulation has been applied as acounterstimulation to overwhelm or swamp pain.(75)

If a counterstimulus could be applied to a RLS patient at the onset ofan attack while the patient were in bed, and the counterstimulus couldbe applied with minimal waking of the patient, sleep efficiency might beimproved. As shown by FIG. 2, which illustrates a flow chart showinggrades of severity of RLS and types of treatments based upon severity,adapted from Chaudhuri, many patients with mild forms for RLSspontaneously apply a counterstimuli of one sort or another to allowthemselves to go back to sleep.(9)

If the RLS patient's self-treatment proves ineffective or if it requiresa degree of wakefulness incompatible with a good night's sleep, then adevice that applied a counterstimulus without robbing sleep might beuseful.

FIG. 3 illustrates a cooling pad, embodying principles of the presentinvention, applied to a leg, the cooling pad applying no additionalpressure than the patient sheet and mattress pad. In some patients,therapeutic counterstimulation could be as simple as making a region ofthe patients bedding cool, as shown in FIG. 3. Cooling that does notdrop to lower than 17° C. is sensed by free nerve fibers as a coolsensation and not pain. Below 17° C., the sensation is identified byother free nerve fibers as pain.(67) (Similarly, above 42° C., heat isno longer sensed as warmth, but as pain.) If the cooling could be turnedon at the onset of RLS symptoms and set to turn off as the patient fellback to sleep, a counterstimulation of a single nerve pathway might besufficient to overwhelm the central sensations of RLS.

FIG. 4 illustrates a hard rubber ball, embodying principles of thepresent invention, being pressed against a patient's leg such that theskin, subcutaneous tissue, muscle, periosteum, and joints are alleffected by the stimulus. In another patient, therapeuticcounterstimulation might require the recruitment of a host of somaticsensory nerves to overcome the unpleasant sensations of RLS. FIG. 4shows a ball pressed against the back of a patients leg with just enoughforce not to elicit pain. Free nerve endings, Merkel's disks, andRuffini's corpuscles from the skin, Pacinian corpuscles fromsubcutaneous tissue, muscle spindles from the muscle, joint receptorsfrom the knee and ankle, and Pacinian corpuscles from the interosseousmembrane joining the tibia and the fibula, could all send somaticsensory signals to the brain from this stimulus. If pressure from aball, or the like, could be applied at the onset of RLS symptoms andremoved as the patient fell back to sleep, a counterstimulation from ahost nerve pathways might sufficient to overwhelm the unpleasant centralsensations of RLS. A commercially available boot which diffusely appliespressure to the foot and calf has been disclosed on the world wide web(club-cleo.com/cleo-active-leggings-reflexology.html) and offered as ameans of treating RLS. Similarly, a boot-like device capable of movingleg fluids to prevent deep vein thrombosis is revealed by Morgenlanderin U.S. Published Patent Application Nos. 2003/0176822 A1, US2005/0026912 A1, and US 2006/0287621 A1, in which the affected limb issubjected to “ . . . positive pressure to an extremity” to effecttreatment. Additionally, in U.S. Pat. No. 4,149,529, Copeland disclosesan apparatus capable of applying pressure to a leg similar toMorgenlander.

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SUMMARY

According to a first aspect of the invention, a system for generating acounter-stimulation in a patient suffering from RLS comprises a deviceconfigured and arranged to generate a counter-stimulation in a patientsuffering from RLS, the counter-stimulation of an amplitude, intensity,and time duration lower than that which would wake the patient andhigher than that sufficient to relieve RLS, or sufficient to relieve RLSsymptoms and allow the patient to return to sleep, a controllerconfigured and arranged to drive the counter-stimulation generationdevice, the controller in communication with the counter-stimulationdevice, and a base configured and arranged to hold thecounter-stimulation generation device adjacent to a patient, thecounter-stimulation device attached to the base.

According to another aspect of the present invention, a method oftreating RLS comprises selecting a patient experiencing RLS, andstimulating a portion of the patient at an amplitude, intensity, andduration sufficient to act as a counter-stimulation to RLS.

Still other aspects, features, and attendant advantages of the presentinvention will become apparent to those skilled in the art from areading of the following detailed description of embodiments constructedin accordance therewith, taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention of the present application will now be described in moredetail with reference to exemplary embodiments of the apparatus andmethod, given only by way of example, and with reference to theaccompanying drawings, in which:

FIG. 1 illustrates a human leg including anatomical features;

FIG. 2 illustrates a decision flow chart relating to the treatment ofRLS;

FIG. 3 illustrates a human leg and the calf thereof;

FIG. 4 illustrates a human leg with the calf thereof resting on a ball;

FIG. 5 illustrates a human leg with a RLS counter-stimulation deviceembodying principles of the present invention positioned on the foot;

FIG. 6 illustrates a human leg with a RLS counter-stimulation deviceembodying principles of the present invention positioned on the calf;

FIG. 7 illustrates a human leg with a RLS counter-stimulation deviceembodying principles of the present invention positioned on the thigh;

FIG. 8 illustrates a human leg with a RLS counter-stimulation deviceembodying principles of the present invention positioned on the foot andcalf;

FIG. 9 illustrates a human leg with a RLS counter-stimulation deviceembodying principles of the present invention positioned on the foot andankle;

FIG. 10 illustrates a human leg with a RLS counter-stimulation deviceembodying principles of the present invention positioned on the foot,calf, and thigh;

FIGS. 11-14 illustrate cross-sectional views, taken a line A-A in FIG.10, showing several features of embodiments of the invention;

FIG. 15 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, under a patient's legs;

FIG. 16 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, over a patient's legs;

FIGS. 17 and 18 illustrate cross-sectional views, taken a line A-A inFIG. 10, showing several features of other embodiments of the invention;

FIG. 19 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, under a patient's legs;

FIG. 20 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, over a patient's legs;

FIG. 21 schematically illustrates an exemplary device for producingcounter-stimulation by pressure application;

FIGS. 22-25 illustrate cross-sectional views, taken a line A-A in FIG.10, showing several features of other embodiments of the invention;

FIGS. 26-28 illustrate side elevational views of embodiments of a devicein accordance with the present invention, under a patient's legs;

FIG. 29 schematically illustrates an embodiment of a device whichmechanically produces vibration counter-stimulation;

FIG. 30 a illustrates a side elevational view of an embodiment of adevice in accordance with the present invention, under a patient's legs;

FIG. 30 b illustrates a side elevational view of an embodiment of adevice in accordance with the present invention, over a patient's legs;

FIGS. 31 and 32 illustrate cross-sectional views, taken a line A-A inFIG. 10, showing several features of other embodiments of the invention;

FIG. 33 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, under a patient's legs;

FIG. 34 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, over a patient's legs;

FIGS. 35 and 36 illustrate cross-sectional views, taken a line A-A inFIG. 10, showing several features of other embodiments of the invention;

FIG. 37 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, under a patient's legs;

FIG. 38 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, over a patient's legs;

FIGS. 39 and 40 illustrate cross-sectional views, taken a line A-A inFIG. 10, showing several features of other embodiments of the invention;

FIG. 41 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, under a patient's legs;

FIGS. 42 and 43 illustrate cross-sectional views, taken a line A-A inFIG. 10, showing several features of other embodiments of the invention;

FIG. 44 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, under a patient's legs;

FIG. 45 illustrates a side elevational view of an embodiment of a devicein accordance with the present invention, over a patient's legs;

FIGS. 46 and 47 illustrate cross-sectional views, taken a line A-A inFIG. 10, showing several features of other embodiments of the invention;

FIGS. 48 and 49 illustrate yet another embodiment of a device for RLScounter-stimulation;

FIGS. 50 and 51 illustrate another embodiment of a device for RLScounter-stimulation;

FIGS. 52 and 53 illustrate yet another embodiment of a device for RLScounter-stimulation;

FIGS. 54 and 55 illustrate another embodiment of a device for RLScounter-stimulation;

FIG. 56 illustrates another embodiment of a device for RLScounter-stimulation;

FIG. 57 illustrates a cross-sectional view, taken at line B-B in FIG.56;

FIGS. 58 and 59 illustrate yet another embodiment of a device for RLScounter-stimulation;

FIG. 60 illustrates yet another embodiment of a device for RLScounter-stimulation;

FIG. 61 illustrates an exemplary system for RLS counter-stimulation;

FIGS. 62 and 63 illustrate yet another embodiment of a device for RLScounter-stimulation;

FIGS. 64 and 65 illustrate yet another embodiment of a device for RLScounter-stimulation;

FIGS. 66-70 illustrate another embodiment of a device for RLScounter-stimulation; and

FIGS. 71-73 illustrate another embodiment of a device useful forproducing mechanical vibrations for RLS counter-stimulation.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

It is believed that that most people in the RLS-suffering population areundiagnosed or symptoms are not sufficient to seek treatment. Most ofthose that do seek treatment are adequately treated by teaching improvedsleep hygiene. A few patients may only be amenable to treatment bydopamine, as the symptoms are so severe that counter stimulation of thepatient does not relieve or prevent the symptoms. Thus, those falling ina middle group, who do not benefit from sleep hygiene training and forwhich neuro-active drugs are an extreme treatment, can particularlybenefit from additional therapeutic options.

TABLE 1 Top Level RLS Treatment Matrix RLS Mild symptoms Symptoms Mildto Severe Severe Patient May be Sleep is Sleep is nearly Experienceundiagnosed occasionally continuously and interrupted and interrupteduntreated patient nearly seeks medical attention Treatment Sleep hygieneCounter Pharmacologic required may be stimulation to treatment aftersufficient prevent the failure of lesser therapy sensory seizuretherapies provides adequate relief

Referring back to FIG. 2, an exemplary process of diagnosing andtreating RLS is illustrated. With reference to Table 1 and FIG. 2, thedetermination that an RLS-sufferer has mild symptoms, 10, indicates thatsleep hygiene may be sufficient therapy for the patient. When adetermination is made that the patient's RLS is severe, 14, then othertreatment options, such as pharmacologic treatment after the failure oflesser therapies, is indicated. In between, when a determination hasbeen made that the patient's RLS is, thus, mild to severe, 12,counter-stimulation, to prevent the sensory seizure, can provideadequate relief to the patient, and is indicated. Particularlyadvantageous, however, are aspects of the present invention in which thecounter stimulation of the patient is conducted within a stimulationwindow, with a level of stimulation high enough that it acts to counterthe “hallucination” discussed above, while being below a level whichwill awaken the patient.

Turning now to FIG. 5, an exemplary embodiment of a device 100 isillustrated by which stimulation can be applied to the patient's footonly, but can be applied to the bottom, top, side, or any combinationthereof. With reference to FIG. 6, another exemplary embodiment of adevice 110 is illustrated by which stimulation can be applied to thepatient's calf only, to the shin, or in combination. With reference toFIG. 7, yet another exemplary embodiment of a device 120 is illustratedby which stimulation can be effected to the patient's thigh only, byapplying stimulation to the front, back, side, or in any combinationthereof.

For example, combined stimulation can be applied to the patient's footand calf, as illustrated in FIG. 8, either in a stimulation sequence orin unison. With reference to FIG. 9, the counter-stimulation can takethe form of the application of motion to part of the patient's body,e.g., a torsion device 130 can be used to flex the patient's ankle,which may flex unilaterally or bilaterally. In this exemplary device130, the device is driven to produce the flexing of muscles and thesensation of motion to the patient's brain. The exemplary device 130 caninclude a portion 132 which, similar to the device 100, is shoe-shapedso that it follows the contours of the patient's foot, a hinge or pivot134 to which the shoe-shaped portion 132, and an ankle cuff 136 alsoattached to the pivot. Not illustrated in FIG. 9 is a motor, linearactuator, or the like which is connected to the shoe-shaped portion 132and selectively moves the portion 132 relative to the patient's calf.With reference to FIG. 10, an embodiment is illustrated whichexemplifies a combined counter-stimulation, in which stimulation of allthree areas (foot, lower leg, thigh) simultaneously, or any two incombination, is utilized. FIG. 11, which illustrates a cross-sectionalview at line A-A in FIG. 10, illustrates that the stimulation can beperformed around the full circumference of the thigh or lower leg; FIG.12, which also illustrates a cross-sectional view at line A-A in FIG.10, illustrates how stimulation can performed over only a portion of thecircumference of the thigh or lower leg; the invention is not limited toapplication of counter-stimulation to the calf, as the illustration ofFIG. 12 is merely exemplary.

FIGS. 13 and 14 illustrate exemplary embodiments, in whichcircumferential pressure is applied to a portion of the patient's body.In an exemplary embodiment illustrated in FIG. 13, a circumferentialbladder 140, which can be pneumatic or hydraulic, applies low pressureto the patient to stimulate, but not at a level sufficient to pumpblood, as in venous boots; 3-20 mm Hg of pressure is preferred. Withreference to FIG. 14, a semi-circumferential bladder 142 applies lowerpressure to stimulate the patient, but not pump blood, and similarly3-20 mm Hg of pressure can provide counter-stimulation. Not illustratedis a fluid pump and controller connected to the bladder 140, 142, whichsupplies fluid at pressure to the bladders so that the bladder canstimulate.

Further embodiments embodying principles of the invention involve theapplication of mechanical point pressure to the patient as a counterstimulation to RLS. With reference to FIG. 15, an exemplary device 150includes a single (or array of) pneumatic cylinders, electric solenoids,inflatable balloons, or similar mechanical point pressure applicators152 which can be used to apply a controlled counter-stimulation to aportion of the patient's body, here the bottoms of the patient's legsbeing illustrated by example; a pillow block 154 can optionally beprovided for comfort, elevation, and to house the mechanisms andcontrols which activate the point pressure applicators. Similarly, withreference to FIG. 16, an exemplary device 160 includes a single (orarray of) pneumatic cylinders, electric solenoids, inflatable balloons,or similar mechanical point pressure applicators 162 which can be usedto apply a controlled counter-stimulation to a top portion of thepatient's body; a blanket or pad 164 can optionally be draped over thepatient's legs for comfort, and to mount the devices.

For embodiments employing pneumatic point pressure application, withreference to FIGS. 17 and 18, one or more inflatable balloons 170 can beused for local pressure stimulation. Advantageously a cuff is not used,because a cuff is prone to cause blood movement, a treatment associatedwith venous disorders, which is too strong of a counter-stimulation formost patients to not be awoken. The focal pressure applied to thepatient, according to principles of the invention, is sufficient toprovide sensory input, but not so much as to move blood in the patient'svenous systems and particularly advantageously does not wake thepatient.

FIG. 19 illustrates a system 180 embodying principles of the invention,in which mechanical touch is utilized to produce counter-stimulation. Byway of a non-limiting example, rollers 182 are provided which spin ontheir axes and may optionally track along the patient's leg, optionallyhoused within a pillow block 184 as discussed above. The roller itselfoptionally is formed of or covered with a soft foam which drags on thepatient's skin, or hard rubber. The rollers may be fixed in position androtate, causing friction, or, alternately, the rollers may be on a track186 and move along the patient as they rotate, rolling over thepatient's skin to stimulate an area.

With reference to FIG. 20, yet another embodiment 190, complying withprinciples of the invention, also relies on the mechanical-touchprinciple to provide counter-stimulation to RLS. Soft or hard rollers192 are used to drag or “roll” on the patient's skin, in a mannersimilar to the rollers described with reference to FIG. 19. A blanket orpad 194 can be provided on top of the patient's legs, both for comfortand to mount the devices.

With reference to FIGS. 21-23, electromechanical or pneumatic cylinders200 embodying principles of the invention are illustrated for providingcounter-stimulation to RLS. An electrical solenoid 202 can be positionedto provide local pressure stimulation, and can be electrically powered,e.g., 12/24 VDC or 120 VAC, as at 204, to provide a pressure timingmechanism to control an “on” pressure cycle and an “off” rest cycle. Thepressure can be adjusted to drive the voltage applied to the solenoid.Additionally, the maximum and minimal travel distances of the pad/rod208, and frequency, can be made variable. The cylinder or cylinders 200can be mounted to a wrap or other support 210, similar to suchstructures described elsewhere herein, with the pressure pad 206directed toward the patient.

With reference to FIG. 23, air pressure can be supplied to providehydraulic pressure on a “pancake” cylinder 220 to minimize the profileof the device. A controller (not illustrated) is provided to increasepressure to create more force on the cylinder rod, decrease pressure toreduce the force on cylinder rod, can ramp or the fluctuate pressure tocreate a “massage”, and/or can adjust the frequency and/or amplitude tomake the stimulation more vibratory.

With reference to FIGS. 24 and 25, which are illustrations ofcross-sectional views similar to prior figures, a touch and rollembodiment is illustrated. As illustrated in FIG. 24,circumferentially-applied counter-stimulation utilizes powered rollers230, which may be solid or foam, and which drag on the skin or rollalong the skin. Optionally, the surfaces of the rollers can be providedwith an extra texture, e.g., dimples, for additional sensation. Withreference to FIG. 25, localized transmission of a counter-stimulationfor treating RLS can be applied by a powered roller, e.g., on one sideof the foot, lower leg, or thigh, which likewise drags on the skin orrolls along the skin.

According to yet further principles of the invention,counter-stimulation for treatment of RLS can be produced by stretchingthe patient's muscle(s). With reference to an exemplary embodimentillustrated in FIG. 26, a device 240 is provided, such as an airbladder, pneumatic cylinder, or a simple mechanical lift 242, whichcauses the thigh muscles 244 to flex as the patient's knee is lifted.Similarly, the calf 246 is flexed as the patient's knee is lifted. Theflexion of either or both of these muscles provides acounter-stimulation to RLS. With reference to FIG. 27, an exemplarydevice includes an air bladder or pneumatic cylinder 252 which can bepositioned under the lower legs and feet of the patient; movement upcauses the thigh muscles to flex and stretch, thus providing acounter-stimulation. With reference to FIG. 28, a footboard 260 isprovided which, upon actuation of an appropriate mechanism to push theupstanding portion 266 of the footboard, flexes and stretches thepatient's calf muscles, providing a counter-stimulation to RLS. By wayof non-limiting example, the footboard 260 can include a relativelystationary platform 268 and a force transmission member 264 connectingthe platform to the upstanding portion 266 at a pivot 262; moving themember 264, e.g., by motor or the like (not illustrated) moves theportion 266 and flexes the patient's foot, causing acounter-stimulation.

According to yet further principles of the invention,counter-stimulation for treatment of RLS can be produced by mechanicalvibration. With reference to an exemplary embodiment illustrated in FIG.29, an electrical motor 270 provided with an eccentric weight 274mounted to the motor shaft 272 can be provided which, upon actuation,rotates the weight and thus vibrates either a local region of thepatient's body or, e.g., the entire leg of the patient to create acounter-stimulation to RLS. Another exemplary embodiment includes apneumatic cylinder or electric solenoid which is driven to cause such avibration, or a piezo-electric vibrator or speaker. With reference toFIGS. 30 a and 30 b, the mechanical vibratory device(s) 270 can bepositioned on top of the patient (FIG. 30 b), as with other embodimentsdescribed herein, with one or more electrical motors provided with aneccentric weight, pneumatic cylinder or electric solenoid 282, and/or apiezo-electric vibrator or speaker 284.

With respect to using vibration as a counter-stimulation for RLS, thevibration can be provided with variable frequency and amplitude, from 1cycle/minute to 1000 cycles/second. By way of non-limiting example,numerous devices can be utilized to create the vibration, including, butnot limited to, a piezo-chip, a loudspeaker, a motor with eccentricweight, an electrical solenoid; and can be electrically driven (120 VAC,12 VDC, 24 DC battery powered, rechargeable, etc.), and/or can be drivenby a pneumatic cylinder. As illustrated in FIG. 31, a series ofvibrators 290 can be provided which wrap around the patient's leg or beapplied to the leg, and can be turned on, run for a predetermined periodof time, and turned off after a specified time. FIG. 32 illustrates anexemplary embodiment in which the vibrator 290 is localized, rather thanbeing provided as a series of vibrators.

According to yet further principles of the invention,counter-stimulation for treatment of RLS can be produced by electricalnerve stimulation, muscle stimulation, or both. With reference to FIGS.33 and 34, an exemplary embodiment 300 includes a series of sensorsand/or electrodes 302 which are activated for muscle stimulation, nervestimulation, or both. When activated for muscle stimulation, the voltageand frequency of the electrical energy applied to the patient issufficient to cause muscular contraction, which provides thecounter-stimulation to RLS; when activated for nerve stimulation, theelectrical energy applied to the patient is sufficient to cause apatient's nerve to be stimulated. For either or both of these purposes,the electrodes and/or sensors are driven by a controller 304, whichcontrols the application of voltage or current to the electrodes 302,and which may be a simple timer, a complex controller, or other suchdevice. With reference to the exemplary embodiments illustrated in FIGS.35 and 36, multi-circuit (circuits 1, 2; electrodes A, B of eachcircuit) stimulation can be applied circumferentially around the, e.g.,leg of the patient, axially, e.g., up and down along the length of thepatient's leg, or both, using sets of electrodes 302. Alternatively,single circuit (A, B) stimulation can be applied laterally and/oraxially, as suggested in FIG. 36.

According to yet further principles of the invention,counter-stimulation for treatment of RLS can be produced by theapplication of temperature changes, e.g., hot, cold, and/or alternatinghot and cold, to the patient. With reference to an exemplary embodiment310 illustrated in FIG. 37, a resistance heating element 312, Peltierdevice 314, and/or a bladder 316 containing heating or chilling fluid ispositioned on the skin surface, below the patient, and an associated(and unillustrated) control device controls application of heat and/orcold to the patient's skin. In FIG. 38's embodiment 320, the heattransfer device 312, 314, 316 is positioned on top of the patient,mounted to a blanket or the like. FIGS. 39 and 40, which areillustrations of cross-sectional views similar to other figures herein,show series of Peltier 314 devices to heat, cool, and/or alternatehot/cold to the patient around a circumference of a, e.g., limb, or asingle device can be provided. Optionally, a series of fluid bladders316 can be provided for holding and/or circulating hot or cold fluid,e.g., water. Alternately, a series of resistive heating pads 312 can beprovided.

According to further principles of the invention, counter-stimulationfor treatment of RLS can be produced by application of a chemical to thepatient's skin. With reference to FIG. 41, an exemplary embodiment 330includes localized ports 332 or a porous membrane 334 positioned on thepatient's skin, to dispense a preselected chemical, thus causing sensorystimulation. With reference to FIGS. 42 and 43, one or more chemicalscan be input to a bladder 336 or diffuser, and provided in either apulsatile or continuous flow. A bladder/diffuser, when used, candispense a chemical such as Bengay™, capsaicin, or DMSO, which providesan exotherm on dissolving into the skin. As indicated in these figures,the chemical application can be completely circumferential, or locally,non-circumferentially applied, where the bladder acts as a manifold forthe chemical.

According to further principles of the invention, counter-stimulationfor treatment of RLS can be produced by application of magnetic fieldsto a portion of the patient. With reference to an exemplary embodiment340 illustrated in FIGS. 44 and 45, one or more electromagnets 342 arepositioned close enough to the patient for the magnetic field to producea counter-stimulation. A controller, not illustrated, is provided tocontrol the operation of the electromagnets, that is, to turn them onand off, alternate the current direction, rotating fixed pole magnetswithin a housing, or combinations thereof. Electromagnets, rotatingfixed pole magnets, or either of these could be sequenced to give somevibration or touch sensation, if desired. As illustrated in thecross-sectional views of FIGS. 46 and 47, electromagnets 342 can bepositioned either circumferentially around a portion of the patient'sbody, or only on one side. In general terms, however, magnets can beprovided which are: electromagnets which are turned on and off to pulsea localized magnetic field; rotating, fixed pole magnets which arerotated in a housing; and/or a magnetic button or malleable magneticrod.

FIGS. 48 and 49 illustrate yet a further embodiment 350 in accordancewith principles of the present invention. One or multiple sensory inputdrivers 352 are positioned in a line on a wrap 358, sized so that theline of sensors can be positioned along a predetermined portion of thepatient's body. By way of a non-limiting example, the wrap is sized tofit around an adult human's calf or thigh, and includes fasteners 356 onrespective portions 354 of the wrap so that the wrap can be held ontothe patient (e.g., hook-and-loop-pile-type fasteners, e.g., Velcro-brandfasteners, magnetic strips, hook-and-eye fasteners, snaps, laces, etc.)with the sensors in sufficient contact with the patient to perform theirrespective sensing and/or stimulation function. Alternatively, asillustrated in FIGS. 50 and 51, another exemplary embodiment 360includes two or more lines 362, 364 of sensors, or the same or differenttypes, can be provided in the wrap. FIGS. 52 and 53 illustrate anembodiment 370 in which the stimulator(s)/sensor(s) are positioned incircumferential bands 372, 374, while the exemplary embodiment 380illustrated in FIGS. 54 and 55 includes axial bands 382, 384 ofstimulator(s)/sensor(s).

The sensory input drivers described herein are connected to a controller(not illustrated) which includes logic, either in one or more electroniccircuits, or in a set of logical instructions which are provided in amemory, and with a processor which can access the memory and execute theset of instructions based on the signals received from the sensory inputdrivers, to drive one or more of the devices described herein to createa counter-stimulus for RLS.

FIGS. 56 and 57 illustrate an example of a device 390 embodyingprinciples of the present invention. A plurality of DC motors 394 arepositioned on or in a foam (e.g., polyurethane foam) body 392, which isadvantageous, yet optionally, flexible, optionally with an outer jacket396 of, e.g., neoprene. The motors are each connected to a relay whichreceives a control signal from a suitable controller. The controllerprovides a signal to the relay to actuate the motors for a predeterminedduty cycle. For example, the duty cycle could be that the motors are onfor between 1 and 180 seconds, and off for between 1 and 18 seconds. Asdescribed above, the motors, when supplied with electricity during an“on” portion of a cycle, turn to produce a counter-stimulation, e.g., byhaving the motor produce mechanical vibration.

FIGS. 58 and 59 illustrate yet another exemplary embodiment 410, inwhich an electric motor 414, fed by a voltage source via leads 419, isencapsulated in a flexible material 412, 418, e.g., neoprene, with ahemispherically shaped cover 416 over the motor; when actuated, asdescribed herein, the motor produces a counter-stimulation that can befelt by the patient through the underlying neoprene 418.

FIG. 60 illustrates yet another exemplary embodiment 400 of a simplecage or jack device which can be used to produce a counter-stimulation.An actuator rod 406 extends through a set of links 402 joined togetherat pivots 404, with the actuator rod connected to an end pivot on an endof the device opposite where the actuator rod extends through a slidepivot 408; alternatively, the rod can be a screw, and the slide replacedwith a nut. Motion of the rod 406 (suggested by the double-ended arrow)through the slide 408 pulls the end pivot toward the slide pivot,causing the links 402 of the cage to move at their pivots 404 and pushthe upper link up, relative to the lower link, as suggested by thearrow. By positioning the cage device 400 adjacent to the skin of apatient, and connecting the actuator rod 406 to a linear actuatorcontrolled by a controller (neither illustrated), pressure and/orvibration can be applied to the patient as a counter-stimulation to RLS.

In general terms, mechanical vibration used as a counter-stimulation toRLS advantageously is in a range of frequencies between about 50 Hz to10 per minute, with amplitudes which can be frequency-dependent, rangingfrom about 0.002 inches to about 0.75 inch in amplitude. While otherfrequencies and amplitudes can be used, these ranges are preferred.Determining the best combination of frequency and amplitude of themechanical vibration for a particular patient can be easily performed bysimple trial and error.

In general terms, temperature cycling used as a counter-stimulation toRLS advantageously is in a range for heating the pad or sensor from theambient skin temperature up to about 106° F., although temperatures upto 120° F. can also be beneficial. For cooling, the pad/sensor is at atemperature from about ambient skin temperature down to 62° F., althougha temperature as low as 52° F. can also be beneficial. One exemplarycycle could include the following: from ambient temperature, heat toskin to a target temperature (e.g., 106° F.) within 2-20 seconds; holdthe temperature at the target temperature for 2-20 seconds; and thencool, either passively or actively, down to ambient temperature; andrest for between 2 seconds and one minute. Another exemplary cycle couldinclude the following: from ambient temperature, cool to skin to atarget temperature (e.g., 62° F.) within 2-20 seconds; hold thetemperature at the target temperature for 2-20 seconds; and then heat,either passively or actively, up to ambient temperature; and rest forbetween 2 seconds and one minute. The total cycle time can be betweenabout 6 second to 90 seconds for ramping up the temperature, maintainingtemperature, and ramping down, with a “rest” period of 2 seconds to oneminute.

In general terms, tissue massaging used as a counter-stimulation to RLSadvantageously is effected with a contact surface against the skin ofthe patient which is domed, e.g., hemispherical, with an outer diameterbetween about 0.5 inch and 1.0 inch, and with a linear motion into thepatient's skin of between 0.01 inches and 1.5 inches. While this motioncan be controlled with a stepper motor to control motion and flexibilityof the design, other devices can also be used. The deflection time of,e.g., the jack illustrated in FIG. 60, should be from 0.5 seconds to 5seconds, with a hold time of between about 1 and 10 seconds, arelaxation deflection time of 0.5 to 5 seconds, and a rest time of 1 to30 seconds.

More timing functions, particularly for continuous, low-amplitudevibration, and starting and stopping the vibration for varied periods oftime, is also beneficial. By way of a non-limiting example, a timingrelay can be used to cycle vibrating motors on and off, with timingcycles ranging from 1 second to 180 seconds on, and “off times” rangingfrom several seconds to 3 minutes. Typical, however, times for use are30 seconds on, with a 5 to 10 second off period. The relay cycles inthis manner for 5 minutes to relieve symptoms, although up to 20 minutesof cycling can be used to alleviate RLS symptoms completely through thenight.

Whether vibration, heat, cold, or massage, a range of operation from 5minutes to 30 minutes should be sufficient to act as acounter-stimulation for many patients. At the end of cycling, a rampdown in intensity of the stimulation may also be beneficial, so as notto waken or alarm the patient due to sudden stoppage which mightreawaken the patient if they have fallen back asleep.

FIG. 61 illustrates a highly schematic view of a relationship betweenone or more sensor(s), one or more controller(s), and one or morecounter-stimulation generators embodying principles of the invention. Asdescribed herein, one or more sensors are in sufficient proximity to asufferer of RLS that it can sense a body condition of the patientindicative of an RLS episode. The sensor(s) generates and transmits asignal to the controller(s), which could be wired or wirelesslyconnected. The controller includes logic, embodied either in one or moreelectronic circuits, or in a set of logical instructions which areprovided in a memory. When provided in a memory, the controller(s)include a processor which can access the memory and execute the set ofinstructions based on the signals received from the sensor(s), togenerate an output signal. The controller(s) are in communication (wiredor wireless) with the counter-stimulation generators, as describedthroughout this disclosure, to drive one or more of the generators tocreate a counter-stimulus for RLS. Because the details of thecontroller's construction are well within the skill of the ordinaryroutineer, they are not provided here so as to not obscure other aspectsof the invention.

FIGS. 62 and 63 illustrate yet another exemplary embodiment 420 of a RLScounter-stimulation device embodying principles of the presentinvention. In general terms, the device 420 includes a removable sleeveto which at least one, and advantageously, yet optionally, multiplecounter-stimulation devices are mounted. The sleeve is configured sothat it can be worn by a RLS-sufferer, and more particularly on thesufferer's limb. While the exemplary device 420 is configured to beeasily worn around an arm or leg, at the elbow or knee, respectively,the device 420 is not so limited and can be differently configured sothat it can be worn around other parts of the sufferer's body so as tobring the counter-stimulation device(s) into contact with that portionof the body at which counter-stimulation is most effective against RLS.

Turning back to the drawing figures, the exemplary device 420 includes afront shell 422 and a rear shell 424, one or both formed of a relativelystiff, preferably polymeric material, e.g., polyethylene orpolypropylene; when only one of the shells is formed of the stiffmaterial, the other can be formed of a flexible material, or can be notincluded at all in the device. The front shell 422 includes upper 426and lower 428 portions, while the rear shell 424 similarly includesupper 430 and lower 432 portions. The upper and lower portions of theshells are advantageously separated by openings 434, 436, the frontopening 434 being sized to be capable of receiving an kneecap (patella)or elbow therethrough. When configured to be worn by a patient's leg orarm, the shells are formed at an angle (see FIG. 63) between the upperand lower portions, so that the leg or arm is comfortably bent whenwearing the device 420. The shells 422, 424, when two shells areprovided, are held together and to the patient by at least one, andpreferably a pair of bands 438, 440, positioned at the top and bottom ofthe shell(s). The band can be simple elastic bands, or are morepreferably adjustable, e.g., including hook-and-loop-pile type or otherfastener systems (e.g., Velcro), so that the device 420 can be adjustedto the patient.

At least one, and advantageously several counter-stimulation devices 442are attached or mounted to the shells 422, 424. The counter-stimulationdevices 442 can take any of the forms described herein. In oneembodiment, the counter-stimulation device 442 is one that producesmechanical vibrations, and can either be in contact with the patient'sskin through the inside surface of the shells 422, 424, or can alsovibrate the entire shell 422, 424, to produce counter-stimulation. Theembodiment illustrated in FIGS. 62 and 63 includes devices 442 on boththe front 422 and rear 424 shells, and the upper and lower portionsthereof; more or fewer devices 442 can be provided as needed for anyparticular patient in order to create an adequate counter-stimulationvibration. The controllers and energy sources which drive the devices442 are not illustrated so as to not obscure aspects of the invention.

FIGS. 64 and 65 illustrate embodiments 450 similar in many respects tothose illustrated in FIGS. 62 and 63, except that the devices 442 aremounted to a flexible sleeve 452, e.g., Neoprene, Lycra, a knit fabric,or the like, which can stretch and confirm to an arm or leg, withpockets formed in the sleeve in which the devices 442 are received. Thesleeve can be straight or, as illustrated, preformed at a comfortableangle.

FIGS. 66-70 illustrate yet another device 460 embodying principles ofthe present invention. When the locus of counter-stimulation for apatient suffering from RLS is advantageously applied to the patient'scalf, the device 460 is adapted to be worn by the patient on the calf sothat counter-stimulation be applied there. The device 460 includes arigid shell 474 which is elongate and concave in the shape of a person'scalf, with a correspondingly shaped flexible liner 462. The liner 462and the shell 474 can include structures which allow the device 460 tobe adjustably worn by the patient; in the embodiment illustrated, slits464, 480 are provided for the passage of (unillustrated) straps, howeverother structures can be used in addition or instead. The shell 474includes one or more holes, cutouts, or windows 476, 478, through whichat least one, and optionally multiple counter-stimulation devices areattached to the shell. In the exemplary embodiment illustrated, thecounter-stimulation device is a mechanical vibration device, here amotor and housing 466 are received in the seat 470 of a motor shell 468,with one or more optional spacers or shims 472 positioned between thehousing 466, shell 474, and liner 462. With the shells 468 extendingoutward through the hole 476, 478, the motor 466 vibrates the device 460and/or the adjacent patient's skin, causing a counter-stimulation toRLS. According to another embodiment, the shell 474 can be formed in thewell known shape of a shinguard and worn one the patient's shin.

FIGS. 71-73 illustrate an exemplary embodiment of a device 490 which canproduce mechanical vibrations suitable for use as a counter-stimulationto RLS in any of the other embodiments described herein. The device 490includes a housing 492 in the open interior of which an electric motor494 is received. The motor 494 includes a shaft 504 extending from themotor, which rotates when the motor is energized. A motor cap 496 ispositioned around the shaft to retain the motor in the housing 492. Acounterweight 498 having a throughhole 502 is mounted on the shaft 504;the hole is offset from the center of mass of the counterweight so that,when rotated, the counterweight creates a vibration. When thecounterweight is cylindrical, as illustrated, the hole is thereforeoffset from the center axis of the cylinder; when the counterweight hasanother shape or uneven mass distribution, the hole is offset from thecenter of mass of the counterweight.

For some patients, effective counter-stimulation to RLS symptoms includemechanical stimulus at low frequencies, for which a rotating motor withan eccentric weight may not provide adequate relief. For such patients,the present invention also includes a solenoid, a geared mechanicalactuator, or a cam lobe that are rotated or otherwise actuated toproduce a low frequency, e.g., 1 to 20 Hz. Additionally, a brushlessmotor may be a requirement for the medical devices described herein, asthe RF emissions for the brushes and the motor moving within its ownmagnetic field may be dangerous for patients with pacemakers orimplantable defibrillators, were a motor with brushes used. Also, thesmaller controllers and drive circuitry are sensitive to induced noise,so extreme filtering or shielding would be required to produce anadequately safe device for this purpose.

In a highly simplified form, systems embodying principles of the presentinvention include a simple on/off button or switch (not illustrated)which can be actuated by the patient when desired to generate acounter-stimulation to RLS symptoms. When actuated, the button simplycommunicates a signal to the controller to begin generating thecounter-stimulation. More complex embodiments include sensors inaddition to or instead of an on/off button, which sensors are mounted inpositions relative to the patient to sense conditions indicative of RLSsymptoms, and to communicate signals to the controller that thegeneration of counter-stimulation is indicated. As such sensors are wellknown to those of ordinary skill in the art, a detailed descriptionthereof will not be presented herein so as to not obscure aspects of theinvention.

While the invention has been described in detail with reference toexemplary embodiments thereof, it will be apparent to one skilled in theart that various changes can be made, and equivalents employed, withoutdeparting from the scope of the invention. The foregoing description ofthe preferred embodiments of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed, andmodifications and variations are possible in light of the aboveteachings or may be acquired from practice of the invention. Theembodiments were chosen and described in order to explain the principlesof the invention and its practical application to enable one skilled inthe art to utilize the invention in various embodiments as are suited tothe particular use contemplated. It is intended that the scope of theinvention be defined by the claims appended hereto, and theirequivalents. The entirety of each of the aforementioned documents isincorporated by reference herein.

We claim:
 1. A system for generating a counter-stimulation in a patientsuffering from restless leg syndrome, the system comprising: a vibrationgenerator configured and arranged to generate a counter-stimulationvibration in a patient suffering from restless leg syndrome, thecounter-stimulation having a frequency of between 1 cycle/minute to 1000cycles per second and an amplitude and duration sufficient to act as acounter-stimulation vibration to restless leg syndrome but low enough toallow the patient to sleep; a controller configured and arranged todrive the vibration generator, said controller operable to terminatevibrations after a period of vibration; and a base configured andarranged to hold the vibration generator adjacent to a patient, thevibration generator attached to the base.
 2. The system of claim 1,wherein the controller is configured to ramp down thecounter-stimulation, after a period of vibration, so as not to waken thepatient.
 3. The system according to claim 1, wherein the vibrationgenerator comprises a device selected from the group consisting of apiezo-chip, a loudspeaker, a motor with an eccentric weight, and asolenoid.
 4. The system according to claim 3, wherein the vibrationgenerator comprises an electric motor having a shaft, and a weighthaving a hole therein, the weight positioned on the shaft, the holelocated at a position offset from a center of mass of the weight.
 5. Thesystem according to claim 4, further comprising: a housing attached tothe base; and wherein the weight is located in the housing.
 6. Thesystem according to claim 1, wherein the base comprises a flexiblesheet.
 7. The system according to claim 6, wherein the sheet comprises afoam sheet, the vibration generator positioned in the foam sheet.
 8. Thesystem according to claim 1, wherein the base comprises a rigid shellhaving at least one housing, the vibration generator located in thehousing.
 9. The system according to claim 8, wherein the vibrationgenerator comprises a mechanical vibrator.
 10. The system according toclaim 8, wherein the rigid shell comprises a hole sized and adapted toreceive the kneecap of the patient.
 11. The system according to claim 8,wherein the rigid shell is shaped to at least in part conformingly fitover the thigh of the patient.
 12. The system according to claim 8,wherein the rigid shell is shaped to conformingly fit over the calf ofthe patient.
 13. The system according to claim 1, wherein the basecomprises a flexible and elastic sleeve having at least one pocket, thevibration generator positioned in the at least one pocket.
 14. Thesystem according to claim 1, further comprising: a plurality ofvibration generators attached to the base and in communication with thecontroller.
 15. A method of treating restless leg syndrome, the methodcomprising: vibrating a portion of a patient experiencing restless legsyndrome with a vibration generator at a frequency of between 1cycle/minute to 1000 cycles per second at an amplitude and durationsufficient to act as a counter-stimulation vibration to restless legsyndrome but low enough to allow the patient to sleep; and performingsaid stimulating step while (1) the patient is attempting to sleep and(2) while the patient is experiencing symptoms of restless leg symptoms.16. A method of claim 15, the method further comprising the step of:ramping down the counter-stimulation vibration so as not to waken oralarm the patient.
 17. A method of treating restless leg syndrome, themethod comprising: applying a counter-stimulation generation device to aleg of a patient experiencing restless leg syndrome, saidcounter-stimulation generation device comprising a vibration generator,a controller operable to drive the counter-stimulation generationdevice, and a sleeve or pad for holding the vibration generator, saidvibration generator operable to generate a counter-stimulation having afrequency of between 1 cycle/minute to 1000 cycles per second of anamplitude, and time duration sufficient to relieve restless leg syndromesymptoms but low enough to allow the patient to sleep; operating thecounter-stimulation generation device to provide counter-stimulatingvibration to the legs of the patient, at the onset of a restless legsyndrome episode.
 18. A method of claim 17, the method furthercomprising the step of: ramping down the counter-stimulation vibrationso as not to waken or alarm the patient.
 19. A method of treatingrestless leg syndrome, the method comprising: selecting a patientexperiencing restless leg syndrome; vibrating a portion of the patientwith a vibration generator at a frequency of between 1 cycle/minute to1000 cycles per second at an amplitude, and duration sufficient to actas a counter-stimulation vibration to restless leg syndrome but lowenough to allow the patient to sleep; and initiating said stimulatingstep at the onset of an episode of restless leg syndrome symptoms.
 20. Amethod of claim 19, the method further comprising the step of: rampingdown the counter-stimulation vibration so as not to waken or alarm thepatient.
 21. A method of treating restless leg syndrome, the methodcomprising: selecting a patient experiencing restless leg syndrome;vibrating a portion of a patient experiencing restless leg syndrome witha vibration generator at a frequency of between 1 cycle/minute to 1000cycles per second during a restless leg syndrome episode at an amplitudeand duration sufficient to act as a counter-stimulation vibration tosaid restless leg syndrome episode and either to allow the patient toreturn to sleep or to not wake a sleeping patient; and initiating saidvibrating step at the onset of an episode of restless leg syndromesymptoms.
 22. A method of claim 21, the method further comprising thestep of: ramping down the counter-stimulation vibration so as not towaken or alarm the patient.
 23. A method of treating restless legsyndrome, the method comprising: selecting a patient experiencingrestless leg syndrome; vibrating a portion of the patient with avibration generator at a frequency of between 1 cycle/minute to 1000cycles per second during a restless leg syndrome episode at an amplitudeand duration sufficient to act as a counter-stimulation vibration tosaid restless leg syndrome episode and either to allow the patient toreturn to sleep or to not wake a sleeping patient.
 24. A method of claim23, the method further comprising the step of: ramping down thecounter-stimulation vibration so as not to waken or alarm the patient.25. The method according to claim 23, wherein said patient is asleep;and wherein said vibrating is insufficient to wake the patient.
 26. Themethod according to claim 23, wherein the patient is awake; and whereinsaid vibrating is insufficient to prevent the patient from fallingasleep.
 27. The method according to claim 23, wherein said vibratingcomprises vibrating with an electric motor.
 28. The method according toclaim 15, wherein counter-stimulating vibration is initiated while thepatient is awake; and wherein said vibrating is insufficient to preventthe patient from falling asleep.
 29. The method according to claim 17,wherein counter-stimulating vibration is initiated while the patient isawake; and wherein said vibrating is insufficient to prevent the patientfrom falling asleep.
 30. The method according to claim 19, whereincounter-stimulating vibration is initiated while the patient is awake;and wherein said vibrating is insufficient to prevent the patient fromfalling asleep.
 31. The method according to claim 21, whereincounter-stimulating vibration is initiated while the patient is awake;and wherein said vibrating is insufficient to prevent the patient fromfalling asleep.
 32. The method according to claim 15, wherein thevibrating step is accomplished at an amplitude in the range of about0.002 inches to about 0.75 inches.
 33. The method according to claim 17,wherein the vibration is provided at an amplitude in the range of about0.002 inches to about 0.75 inches.
 34. The method according to claim 19,wherein the vibrating step is accomplished at an amplitude in the rangeof about 0.002 inches to about 0.75 inches.
 35. The method according toclaim 21, wherein the vibrating step is accomplished at an amplitude inthe range of about 0.002 inches to about 0.75 inches.
 36. The methodaccording to claim 23, wherein the vibrating step is accomplished at anamplitude in the range of about 0.002 inches to about 0.75 inches.